Back to resultsA Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Primary Purpose
Hyperbilirubinemia, Neonatal
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Stannsoporfin
Placebo
PhotoTherapy (as needed)
Sponsored by
About this trial
This is an interventional treatment trial for Hyperbilirubinemia, Neonatal focused on measuring Hemolysis
Eligibility Criteria
Inclusion Criteria:
Babies may only participate if they meet all the following criteria:
- Is a term or late preterm baby
- Is at risk for protocol-defined hemolytic disease
- Weighs at least 2500 g (5.5 lbs)
- Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
- Has parents/guardians who are willing to follow light precautions and sign informed consent
Exclusion Criteria:
The following criteria will make a baby not eligible to participate:
- Needs medications that may prolong the QT interval
- Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
- Has an Apgar score of 6 or below at age 5 minutes
- Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results
Sites / Locations
- Arrowhead Regional Med Center
- UCSD Medical Center
- Kapi'olani Medical Center for Women and Children
- University of Louisville
- Westchester Medical Center
- ECU Brody School of Medicine
- St. Vincent Mercy Children's Hospital
- Drexel University College of Medicine, Clinical Research Group
- Albert Einstein Medical Center
- Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care
- Neonatal Department Warsaw Medical University
- Research Institute of Polish Mother's Health Center
- Hospital Vall D´Hebrón
- Hospital Clinic i Provincial
- Complejo Hospitalario Universitario A Coruña
- Hospital Doce de Octubre
- Hospital La Paz
- University Hospital Santiago de Compostela-L Coruna
- Municipal Medical Institution "Regional pediatric clinical hospital #1", Department of pathology of the newborns; Bukovynian State Medical University, Department of Pediatrics and Children's Infectious Diseases
- National Pediatric Specialized Hospital "OHMATDYT".
- State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department
- Municipal Institution "Odessa regional clinical hospital", Department of pathology of the newborns and premature infants; Odessa State Medical University; Chair of Pediatrics #1 and Neonatology
- Vinnytsia regional pediatric hospital, Department of pathology of the newborns, Vinnytsia National Medical University named after M.I.Pirogov, Chair of Pediatrics #1
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Cohort 1: Stannsoporfin 1.5 mg/kg
Cohort 2: Stannsoporfin 3.0 mg/kg
Cohort 3: Stannsoporfin 4.5 mg/kg
Cohort 4: Placebo
Arm Description
Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed.
Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed.
Outcomes
Primary Outcome Measures
Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.
The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time [(TSB - PT threshold/PT threshold) x 100%).
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better.
Secondary Outcome Measures
Full Information
NCT ID
NCT00850993
First Posted
February 24, 2009
Last Updated
October 25, 2019
Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
1. Study Identification
Unique Protocol Identification Number
NCT00850993
Brief Title
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Official Title
A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
To redefine study population
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is a normal process in the human body for red blood cells to die, which makes bilirubin.
Bilirubin is cleared away through the liver.
Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice).
This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high.
Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin.
This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.
Detailed Description
The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbilirubinemia, Neonatal
Keywords
Hemolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Sequential experimental cohorts are run in parallel with placebo controls.
Masking
ParticipantInvestigator
Masking Description
Clinical personnel at the site (including investigator, study coordinator and central cardiologist) were blinded to treatment group.
The research pharmacy and the health care provider responsible for giving the injection to patients knew what the treatment was (they were not blinded).
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: Stannsoporfin 1.5 mg/kg
Arm Type
Experimental
Arm Description
Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed.
Arm Title
Cohort 2: Stannsoporfin 3.0 mg/kg
Arm Type
Experimental
Arm Description
Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Arm Title
Cohort 3: Stannsoporfin 4.5 mg/kg
Arm Type
Experimental
Arm Description
Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Arm Title
Cohort 4: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed.
Intervention Type
Drug
Intervention Name(s)
Stannsoporfin
Other Intervention Name(s)
Experimental product
Intervention Description
Stannsoporfin administered as a single IM injection
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Placebo (sterile saline solution) administered as a single IM injection
Intervention Type
Other
Intervention Name(s)
PhotoTherapy (as needed)
Other Intervention Name(s)
PT
Intervention Description
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Primary Outcome Measure Information:
Title
Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.
Description
The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time [(TSB - PT threshold/PT threshold) x 100%).
Time Frame
Baseline, 48 hours
Title
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
Description
Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better.
Time Frame
Baseline, 48 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Babies may only participate if they meet all the following criteria:
Is a term or late preterm baby
Is at risk for protocol-defined hemolytic disease
Weighs at least 2500 g (5.5 lbs)
Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
Has parents/guardians who are willing to follow light precautions and sign informed consent
Exclusion Criteria:
The following criteria will make a baby not eligible to participate:
Needs medications that may prolong the QT interval
Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
Has an Apgar score of 6 or below at age 5 minutes
Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Arrowhead Regional Med Center
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Kapi'olani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
ECU Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
St. Vincent Mercy Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Drexel University College of Medicine, Clinical Research Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Neonatal Department Warsaw Medical University
City
Warszawa
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Research Institute of Polish Mother's Health Center
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Hospital Vall D´Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
E-08036
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
University Hospital Santiago de Compostela-L Coruna
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Municipal Medical Institution "Regional pediatric clinical hospital #1", Department of pathology of the newborns; Bukovynian State Medical University, Department of Pediatrics and Children's Infectious Diseases
City
Chernivtsi
ZIP/Postal Code
58023
Country
Ukraine
Facility Name
National Pediatric Specialized Hospital "OHMATDYT".
City
Kiev
ZIP/Postal Code
1135
Country
Ukraine
Facility Name
State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department
City
Kiev
ZIP/Postal Code
4050
Country
Ukraine
Facility Name
Municipal Institution "Odessa regional clinical hospital", Department of pathology of the newborns and premature infants; Odessa State Medical University; Chair of Pediatrics #1 and Neonatology
City
Odessa
ZIP/Postal Code
65031
Country
Ukraine
Facility Name
Vinnytsia regional pediatric hospital, Department of pathology of the newborns, Vinnytsia National Medical University named after M.I.Pirogov, Chair of Pediatrics #1
City
Vinnitsa
ZIP/Postal Code
21029
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
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